Validation of HealthCare Standards in Chronic Obstructive Pulmonary Disease

NCT01544543 | Completed

• 1 other identifier: VES0109
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

VESALIO is a pilot study aimed at evaluating the feasibility and reliability (time stability and interobserver reliability) of healthcare quality standards in chronic obstructive pulmonary disease (COPD) recently outlined by SEPAR (Spanish Pneumology and Thoracic Surgery Society), and at establishing the foundation for a future validation (construct and criterion validation) of the aforementioned standards.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (3)

• COPD exacerbation

  Within 12 months after hospitalization

• Mortality

  within 90 and 180 days after hospitalization

• Healthcare-associated cost

  Hospital-stay lenght ER visits

  within 12 months after hospitalization

Study Arms (1)

COPD Exacerbation Cohort

Patients hospitalized for a COPD exacerbation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients hospitalized for an exacerbation of COPD

You may qualify if:

• Men and women 40 years of age or older
• Diagnosis of COPD at hospital discharge
• Hospitalization for a COPD exacerbation

You may not qualify if:

• Patients hospitalized for the first time at the participating site without a documented history of COPD
• Patients currently participating of having ever participated in a COPD-related clinical trial
• Patients with a serious disease that might affect the measured outcomes (terminal oncologic disease, neoplastic disease for which the patient is receiving chemo/radiotherapy, terminal renal insufficiency, AIDS)

Sponsors & Collaborators

• Sociedad Española de Neumología y Cirugía Torácica: lead

Study Sites (1)

Hospital General de Requena

Requena, Valencia, 46340, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan J Soler Cataluna, MD, PhD

  Hospital de Requena, Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: March 6, 2012
• Study Start: February 1, 2010
• Last Updated: March 6, 2012

Record last verified: 2012-02

Locations

ES (1)